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A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-96673
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Relapsed or Refractory, Non-Hodgkin's Lymphoma, CC-96673, Dose Finding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

  1. Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  3. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
  4. Participant must have a history of NHL that has relapsed or progressed.
  5. Participant has tumor accessible for biopsies.
  6. Participant has an ECOG PS of 0 or 1.
  7. Participants must have acceptable laboratory values as specified in the protocol.

Exclusion Criteria:

  1. Participant has cancer with symptomatic central nervous system (CNS) involvement
  2. Participant is on chronic systemic immunosuppressive therapy or corticosteroids or subjects with clinically significant graft-versus-host disease (GVHD). Intranasal, inhaled, topical, or local corticosteroid injections, or steroids as premedication for hypersensitivity reactions are exceptions to this criterion.
  3. Inadequate cardiac function or significant cardiovascular disease
  4. Participant has received prior investigational therapy directed at CD47 or SIRPα.
  5. Participant had major surgery ≤ 2 weeks prior to starting CC-96673.
  6. Participant is a pregnant or lactating female or intends to become pregnant during participation of the study.
  7. Participant has known active human immunodeficiency virus (HIV) infection.
  8. Participant has active hepatitis B or C (HBV/HCV) infection.
  9. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
  10. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
  11. History of concurrent second cancers requiring active, ongoing systemic treatment.
  12. Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  13. Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.

Sites / Locations

  • Local Institution - 104
  • Local Institution - 103
  • Local Institution - 101
  • Local Institution - 102
  • Local Institution - 201
  • Local Institution - 202
  • Hopital Claude Huriez
  • CHU Montpellier - Hôpital Saint Eloi
  • Hopital Lyon Sud
  • Local Institution - 401
  • Local Institution - 403
  • Local Institution - 402

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of CC-96673

Arm Description

CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Dose-limiting toxicity (DLT)
Number of participants with a DLT
Maximum tolerated dose (MTD)
Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.

Secondary Outcome Measures

Overall response rate (ORR)
Is defined as the percent of participants whose best response is CR or PR
Time to response (TTR)
Is defined as the time from the first dose of CC-96673 to tumor response
Duration of response (DOR)
Is defined as the time from tumor response to progression/death
Progression free survival (PFS)
Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause
Pharmacokinetics - Cmax
Maximum observed serum concentration of drug
Pharmacokinetics - AUC
Area under the serum concentration-time curve
Pharmacokinetics - tmax
Time of maximum observed serum concentration
Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies

Full Information

First Posted
April 22, 2021
Last Updated
October 3, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT04860466
Brief Title
A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title
A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
August 20, 2025 (Anticipated)
Study Completion Date
August 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL). The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Relapsed or Refractory, Non-Hodgkin's Lymphoma, CC-96673, Dose Finding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of CC-96673
Arm Type
Experimental
Arm Description
CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
Intervention Type
Drug
Intervention Name(s)
CC-96673
Intervention Description
IV Infusion
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Description
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Time Frame
From enrollment until at least 28 days after completion of study treatment
Title
Dose-limiting toxicity (DLT)
Description
Number of participants with a DLT
Time Frame
Up to approximately 18 months
Title
Maximum tolerated dose (MTD)
Description
Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.
Time Frame
Up to approximately 18 months
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Is defined as the percent of participants whose best response is CR or PR
Time Frame
Up to 2 years after study treatment
Title
Time to response (TTR)
Description
Is defined as the time from the first dose of CC-96673 to tumor response
Time Frame
Up to 2 years after study treatment
Title
Duration of response (DOR)
Description
Is defined as the time from tumor response to progression/death
Time Frame
Up to 2 years after study treatment
Title
Progression free survival (PFS)
Description
Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause
Time Frame
Up to 2 years after study treatment
Title
Pharmacokinetics - Cmax
Description
Maximum observed serum concentration of drug
Time Frame
Up to 24 Months
Title
Pharmacokinetics - AUC
Description
Area under the serum concentration-time curve
Time Frame
Up to 24 Months
Title
Pharmacokinetics - tmax
Description
Time of maximum observed serum concentration
Time Frame
Up to 24 Months
Title
Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies
Time Frame
Up to 24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF). Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. Participant is willing and able to adhere to the study visit schedule and other protocol requirements. Participant must have a history of NHL that has relapsed or progressed. Participant has an ECOG PS of 0 or 1. Participants must have acceptable laboratory values as specified in the protocol. Exclusion Criteria: Participant has cancer with symptomatic central nervous system (CNS) involvement Participant is on chronic systemic immunosuppressive therapy or corticosteroids or subjects with clinically significant graft-versus-host disease (GVHD). Intranasal, inhaled, topical, or local corticosteroid injections, or steroids as premedication for hypersensitivity reactions are exceptions to this criterion. Inadequate cardiac function or significant cardiovascular disease Participant has received prior investigational therapy directed at CD47 or SIRPα. Participant had major surgery ≤ 2 weeks prior to starting CC-96673. Participant is a pregnant or lactating female or intends to become pregnant during participation of the study. Participant has known active human immunodeficiency virus (HIV) infection. Participant has active hepatitis B or C (HBV/HCV) infection. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia. History of concurrent second cancers requiring active, ongoing systemic treatment. Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 104
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Local Institution - 103
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6840
Country
United States
Facility Name
Local Institution - 101
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 102
City
Seattle
State/Province
Washington
ZIP/Postal Code
98124
Country
United States
Facility Name
Local Institution - 201
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 202
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi
City
Montpellier CEDEX 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Local Institution - 401
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Local Institution - 403
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 402
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma

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